Low Intensity Family Support for Refugees in an LMIC

NCT03978533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2021-11-15

No results posted yet for this study

Summary

The rapidly growing scale of humanitarian crises requires new response capabilities geared towards addressing populations with prolonged high vulnerability to mental health consequences and little to no access to mental health, health, and social resources. This R21 develops and pilot tests a novel model for helping urban refugee families in LMICs with little to no access to evidence-based mental health services, by delivering a transdiagnostic family intervention for common mental disorders in health sector and non-health sector settings. The project is located in Istanbul, Turkey. Aim 1 forms a Family Support Design Team (FSDT) to adopt the PM+ and CAFES manuals into a family support (FS) intervention for use with refugee families by lay providers in community sites and nurses in clinical sites using a four-session multiple family group format. Aim 2 pilots FS with families in community and clinical sites, and then through observations and qualitative interviews, assesses FS's feasibility, fidelity, the impact of context and local capacity, the experiences of intervention delivery, and practitioner and organizational perspectives on scale up. Aim 3 conducts pre, immediate post, and 3-month post assessments of the refugee families who received FS through all the sites, to demonstrate the kind of pre-post changes that have been reported for comparable interventions and to determine key parameters of interest with sufficient accuracy and precision. This exploratory investigation, conducted with the support and advice of the World Health Organization, will strengthen the research capabilities of the academic and community partners in Istanbul and will develop new evidence-based mental health services for refugees in Turkey and other LMICs, as well as for refugees and migrants in low resource communities in the United States.

Conditions

Interventions

BEHAVIORAL

Family Support Group

Family Support Groups will be piloted with families in community and clinical sites. Each pair of facilitators will pilot two groups of 6 families each. Each group is 4 sessions lasting 2 hours each. Each of the sessions incorporates didactic talks, family discussion, and separate breakout groups for adolescents and adults. Family Support intervention incorporates cognitive-behavioral theory of PM+ which underlies evidence-based techniques focused on stress management and behavioral activation. Family support intervention also incorporates resilience theory, which explains family protective processes that can ameliorate the negative consequences of hardships and challenges and enable healing and growth in families.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Stevan Weine, MD · University of Illinois at Chicago

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-16
Primary Completion
2021-02-28
Completion
2021-07-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978533 on ClinicalTrials.gov